MAUDE Adverse Event Report: AESCULAP AG CASPAR BIPOLAR FORCEPS 1.0X125/220MM; BIPOLAR TECHNOLOGIES

Model Number GK970R

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with the product gk970r - caspar bipolar forceps 1.0x125/220mm.According to the complaint description, electrocoagulation bipolar adhesion was severe and hemostasis was difficult.This resulted in cerebrospinal fluid (csf) leakage repair, performed under general anesthesia.The patient had been undergoing transnasal sellar space occupying resection under general anesthesia with neuroendoscope.Snake brand bipolar coagulator forceps were used during the operation.The patient was then discharged with improved condition.An additional medical intervention was required.According to manufacturer's reporting evaluation in accordance with 21 cfr 803, section 803.3, this event is considered reportable for the following reason: - serious injury (report not later than 30 days).The assessment for the reportability of this adverse event was based on patient harm, additional medical intervention.Further details were not provided.The adverse event is filed under aesculap ag reference no.(b)(4).

Manufacturer Narrative

Investigation results: the product was not available for investigation, and pictures also were not provided.The investigation results were based on analysis of production records and historical data review.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and the products were found to be according to our specification valid at the time of production.There are no other similar complaints within this batch.According to manufacturer's reporting evaluation in accordance with 21 cfr 803, section 803.3, this event is considered reportable for the following reason: - serious injury (report not later than 30 days).The assessment for the reportability of this adverse event was based on patient harm, additional medical intervention.Conclusion/preventive measures: without the product, a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not necessary.

• Brand Name: CASPAR BIPOLAR FORCEPS 1.0X125/220MM
• Type of Device: BIPOLAR TECHNOLOGIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18542477
• MDR Text Key: 333231753
• Report Number: 9610612-2023-00292
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K770428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GK970R
• Device Catalogue Number: GK970R
• Device Lot Number: RU01262496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention